Randomized Trial Comparing Laparoscopic Roux-en-y Gastric Bypass to Micro-laparoscopic Roux-en-y Gastric Bypass

Completed · Not applicable

Conditions studied: Obesity

In brief

Background Laparoscopy is the preferred surgical approach for a number of different diseases as it allows for diagnosis and treatment in the setting of a safe and feasible method offering enhanced cosmesis. The natural evolution of laparoscopy is micro-laparoscopy which utilizes smaller instruments and optics. Technological advancements have enabled miniaturization of the surgical equipment without compromising diagnostic or operative capabilities. Dr. Keith Zuccala is currently performing micro-laparoscopic gastric bypass with an identical safety profile as traditional laparoscopy (NSQIP data comparison between Dr. Laura Choi and Dr. Keith Zuccala). The current trend in laparoscopy is to minimize incisions and their size to decrease trauma to the abdominal wall. Study Design Both methods have never been compared in a prospective randomized trial to address the following questions. 1. Is there a difference in outcome? 2. Is there a decrease in postoperative pain? 3. Does it decrease time off from work? 4. Does micro-laparoscopy increase OR time? 5. What is the effect on cost of micro-laparoscopy? Patients will be randomized to one or the other method, disclosing that to the investigators best knowledge both methods are equally safe and that Dr. Zuccala has performed several hundred cases using both methods. Patient Population Projected sample size would be 50 patients in each group. Accrual should be feasible over the course of 9-12 months. Data collection (patients will be followed for a total of 30 days for the purpose of this study) 1. NSQIP data to assess outcome 2. Postoperative usage of pain medication while in the hospital 3. Time off from work 4. OR time 5. Direct cost of procedure as it relates to material used

Key facts

Study ID: NCT01183273
Run by: Suzanne J. Rose
People needed: 50
Starts: 2010-03-01
Expected to finish: 2014-07-01
Last updated by the study team: 2014-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

A body mass index (BMI) ≥ 40 with or without co-morbid conditions*
A BMI ≥ 35 with co-morbid conditions*
Permanent lifestyle changes including exercise
No significant, untreated psychiatric illnesses
Age ≥ 18 years
Sufficient ability and cognition to understand surgery, potential complications and subsequent associated changes
Willingness to participate in treatment and long-term follow-up
Proof of failed attempts at non-surgical weight reduction
Acceptable medical/operative risks * Co-morbid solutions include: hypertension, diabetes mellitus, cardiac disease, hypercholesterolemia/hyperlipidemia, sleep apnea, asthma, hypoventilation syndrome of obesity, degenerative joint disease, gastro-esophageal reflux disease, venous stasis ulcers, depression, menstrual irregularities/infertility, polycystic ovary syndrome, fungal skin infections.

You may not qualify if…

The need to convert from laparoscopic roux-n-y to an open abdominal procedure.
Patients with congestive heart failure or other serious illness which would prevent the patient from a successful surgery and recovery
Women who are nursing or pregnant
Patients who smoke
Patient's insurance will not cover the cost of surgery.

Where it is running

Danbury Hospital — Danbury, Connecticut, United States

Full record on ClinicalTrials.gov

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